Phase 2
N=54
723/726 Proof of Concept Study in Allergen Challenge Chamber in Hannover
Rhinitis, Allergic, Seasonal
Bottom Line
View on ClinicalTrials.gov: NCT00972504 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcome: Primary: Weighted Mean TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 — 4.9; 4.2; 3.6; 3.5 Score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- GSK835726 10mg (Drug); GSK1004723 1000mcg (Drug); Cetirizine 10mg (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weighted Mean TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 |
4.9; 4.2; 3.6; 3.5 | — |
| SECONDARY Weighted Mean of the Individual Components of TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 |
1.5; 1.7; 1.3; 1.3; 1.5; 1.3 | — |
| SECONDARY Weighted Mean Wet Tissue Weight (as a Surrogate Marker of Nasal Secretion) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 |
6.251; 5.210; 4.491; 3.459 | — |
| SECONDARY Weighted Mean Nasal Congestion VAS 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 |
3.97; 4.29; 2.92; 2.90 | — |
| SECONDARY Mean Forced Expiratory Volume in 1 Second (FEV1) |
3.908; 3.935; 3.924; 3.932; 3.949; 3.959 | — |
| SECONDARY Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) |
15; 53; 13; 17; 0; 0 | — |
Summary
This is a randomised, double-blind, placebo-controlled 4-period cross-over study to assess the efficacy and safety of repeat dose intranasal GSK1004723 (1000µg), oral GSK835726 (10mg) and cetirizine (10mg) in the environmental challenge chamber in subjects with seasonal allergic rhinitis.
Eligibility Criteria
Inclusion Criteria
- Subject is healthy apart from seasonal allergic rhinitis, as determined by a physician. Can have mild asthma.
- Males or female using contraceptives
- Aged 18 - 65
- Weight 50kg+, BMI 19-32 kg/m2
- Exhibit response to Challenge Chamber and skin prick test.
- Non-smoker
- Capable of giving informed consent
- AST and ALT<2xULN; alkaline phosphatase and bilirubin <or=1.5xULN
Exclusion Criteria
- No nasal structural abnornmality/polyposis, surgery, infection.
- any respiratory disease, other than mild asthma or seasonal allergic rhinitis
- participated in another clinical study within 30 days.
- Subject has donated a unit of blood within 1 month
- Use of prescription or non-prescription drugs, including vitamins and st john's wort within 7 days of trial.
- History of sensitivty to drug
- History of alcohol/drug abuse within 12 months.
- Positive Hepatitis B antibody test
- Positive HIV antibody test
- Risk of non-compliance with study protocol
- Pregnant or llactating females
- Perenial allergic rhinitis
- Administration of oral, injectable or dermal corticosteriods within 8 weeks, intranasal or inhaled within 3 weeks.
- Past or present disease that may affect outcome, as judge by investigator
- Specific Immunotherapy within 2 years
Data sourced from ClinicalTrials.gov (NCT00972504). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.